Lyophilization Process Development (Quality By Design approach)

A correct formulation means greater stability of the active ingredient and provides protection against the stress suffered during the lyophilization process itself.

The selection of the appropriate excipients is really important in the development of a freeze-dried product.

Having information on the thermodynamic behavior our formula is critical to identify the critical product temperatures. At Comser, we have the following technology to characterize the product:

Freeze Drying Microscope (FDM)
Differential Scanning Calorimetry (DSC)

With the aim of obtaining a product that meets the critical quality attributes, but with the most optimized freeze-drying process.

Our focus is the total control of the process. We develop freeze-drying processes in a previously defined design space: Quality By Design approach.

From the laboratory to the industry. 

The key to a correct Scale-Up and Transfer of lyophilization processes is the knowledge of the developed product, as well as the control of the process and the capabilities of the final equipment.

The format of this course is hybrid, you can attend in person or online.

Next edition: November 2022 (in Spanish); May 2023 (in English)

A correct formulation means greater stability of the active ingredient and provides protection against the stress suffered during the lyophilization process itself.

The selection of the appropriate excipients is really important in the development of a freeze-dried product.

Having information on the thermodynamic behaviour of our formula is critical to identify the critical product temperatures. At Comser, we have the following technology to characterize the product:
- Freeze Drying Microscope (FDM)
- Differential Scanning Calorimetry (DSC)

And with such,...

Comser High Value Services Catalogues, broken down into three categories:
- Overview of the whole Comser's value added services
- Formulation & Lyophilization contract services
- GMP Qualification & Validation of critical machinery and processes in aseptic environment